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Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients. (CHICS)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Escalating dose of Casodex from 50mg daily to 150 mg daily
Sponsored by
Canadian Urology Research Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of written informed consent.
  2. Men, over 18 years of age, with histologically-confirmed prostate cancer
  3. Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1
  4. Serum testosterone level < 50 ng/ml
  5. Current treatment with bicalutamide 50 mg daily.**
  6. Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml.
  7. Highest PSA level no greater than or equal to 30 ng/ml.
  8. Life expectancy of greater than 1 year -

Exclusion Criteria:

  1. Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.*
  2. PSA level greater than 30 ng/ml.
  3. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial.
  4. Subjects who have received prior chemotherapy.
  5. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder.
  6. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L.
  7. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
  8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR.
  9. Serum creatinine greater than 1.5 times -

Sites / Locations

  • Sunnybrook Health Sciences Centre

Outcomes

Primary Outcome Measures

Doubling of PSA

Secondary Outcome Measures

Full Information

First Posted
November 5, 2007
Last Updated
May 13, 2011
Sponsor
Canadian Urology Research Consortium
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00554086
Brief Title
Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.
Acronym
CHICS
Official Title
Phase 2 Trial of Maximum Androgen Blockade (MAB) Dose Escalation From 50 mg to 150 mg Bicalutamide (Casodex) for Biochemical Failure in Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Canadian Urology Research Consortium
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Multi-centre one year trial for patients who have rising PSA while on Casodex 50mg daily dose. Casodex dosage escalated to 150 mg tablet daily. Treatment will be continued until patient demonstrates clinical benefit at one year, PSA progression, toxicity, or withdrawal. Treatment will be continued after one year if patient demonstrates continued clinical benefit.
Detailed Description
The study will be a national, multicentre, open-label, phase II trial. Patients who have a rising PSA on MAB with bicalutamide 50 mg daily will be dose escalated to MAB with 150 mg bicalutamide daily. Subjects will receive trial treatment for 12 months, or until disease progression, unacceptable toxicity or withdrawal of consent. Open label treatment will be offered thereafter if the subject demonstrates clinical benefit at the end of one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escalating dose of Casodex from 50mg daily to 150 mg daily
Intervention Description
Casodex dosage increase from 50mg to 150mg daily until baseline serum PSA is reduced by 50%
Primary Outcome Measure Information:
Title
Doubling of PSA
Time Frame
one year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent. Men, over 18 years of age, with histologically-confirmed prostate cancer Treatment with Zoladex (goserelin acetate) for greater than 3 months prior to Day 1 Serum testosterone level < 50 ng/ml Current treatment with bicalutamide 50 mg daily.** Two consecutive rises in PSA above a nadir value, with the absolute value of the latest PSA > 2.0 ng/ml. Highest PSA level no greater than or equal to 30 ng/ml. Life expectancy of greater than 1 year - Exclusion Criteria: Patients may not have received prolonged anti-androgen therapy other than with bicalutamide. Patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.* PSA level greater than 30 ng/ml. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial. Subjects who have received prior chemotherapy. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder. Absolute neutrophil count less than 1.5 x 109/L or platelets less than 100 x 109/L. Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR). Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR. Serum creatinine greater than 1.5 times -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Klotz
Organizational Affiliation
Canadian Urology Research Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.curc.ca
Description
Related Info

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Open Label,Phase II Trial of MAB Dose Escalation OF Bicalutamide For Biochemical Failure In Prostate Cancer Patients.

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